Cold plasma annular array methods and apparatus

ABSTRACT

Methods and apparatus are described that use an array of two or more cold plasma jet ports oriented to converge at a treatment area. The use of an array permits greater tissue penetration by cold plasma treatments. This approach enables treatment of deeper infections of soft and hard tissues without surgical intervention. For example, this approach can treat sub-integumental infections, such as those common to joint replacements, without surgically opening the issues overlying the deeper infection.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional applicationSer. No. 14/145,312, filed Dec. 31, 2013, which claims the benefit ofU.S. Provisional Application No. 61/747,428, filed Dec. 31, 2012 andentitled “Cold Plasma Toroidal Array Methods and Apparatus,” all ofwhich are incorporated herein by reference in their entirety.

This application is related to U.S. Provisional Application No.60/913,369, filed Apr. 23, 2007; U.S. patent application Ser. No.12/038,159, filed Feb. 27, 2008 (which issued as U.S. Pat. No.7,633,231); U.S. patent application Ser. No. 13/620,118, filed Sep. 14,2012; and U.S. patent application Ser. No. 14/026,679, filed Sep. 13,2013, each of which are herein incorporated by reference in theirentireties.

BACKGROUND

Field of the Art

The present invention relates to devices and methods for cold plasmaapplication, and, more particularly, to arrays of such devices that areformed in an annular shape and methods for using same.

Background Art

When infections of deep tissues occur in the body it is often necessaryto perform a surgical procedure to expose the infection, manually cleanor debride the site, pack it with antibiotics, and initiate systemicantibiotics in an attempt to resolve the infection. In the case oforthopedic infections, where there is hardware of metallic or plasticcomposition present, the standard course of treatment may requiremultiple surgical procedures. Since the hardware may be covered inbacterial colonies and there is limited vascularization of the tissuesimmediately contacting the hardware, the colonization of the hardwareoften can't be controlled with systemic antibiotic use alone. In thecase of an infected total joint replacement, the surgeon will oftenperform a “two-stage revision” procedure. The first stage involvesopening the joint, removing the hardware, debriding infected tissue,packing the region with antibiotic impregnated materials, and closingthe incision. Along with systemic antibiotics, the antibiotic materialsare left in the patient, often with a non-functional joint complex, foron average 6 weeks. After blood and joint fluid tests suggest resolutionof the infection, a second procedure is performed to remove theantibiotic laden materials and implant a new functional jointreplacement. In some cases the infection is still present locally eventhough blood indicators are normal, and the new implant may quicklybecome re-infected, starting the “2-stage revision” procedure overagain. In extreme cases, amputation may be the prescribed course ofaction for severe extremity infections that fail to resolve after thesemeasures.

It is therefore highly desirable to be able to eradicate a deep jointinfection without the need for repeated surgeries and a reliance onantibiotics to reach the site either through the circulatory system orby local, internal, long-term application. The same applies to otherbone and deep tissue infections, abscesses, and similar conditionsfamiliar to those in the medical field. As cold plasmas also showpromise in the treatment of malignant growths, this array would have usein the treatment of deep tissue tumors, or any disorder that requiresgreater depth of penetration of plasma, including musculoskeletal painand inflammation.

BRIEF SUMMARY OF THE INVENTION

An embodiment is described of an apparatus having an annular structurewith two or more cold plasma devices located on the annular structureand directed internal to the annular structure so as to converge at atreatment area. The two or more cold plasma devices are coupled to oneor more high voltage RF ports and to one or more gas supply ports.

A further embodiment is described of a method of producing cold plasmafor use in a medical treatment. The method includes receiving, from acold plasma power supply, electrical energy at two or more cold plasmadevices via one or more high voltage RF ports. The two or more coldplasma devices are located on an annular structure. The method alsoincludes receiving, from a gas source, gas at the two or more coldplasma devices via one or more gas supply ports. Finally, the methodincludes outputting cold plasma from the two or more cold plasmadevices, the cold plasma from these cold plasma devices being directedto converge at a treatment area.

BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES

FIG. 1 illustrates an embodiment of the cold plasma annular treatmentdevice that includes an array of a plurality of plasma ports.

FIG. 2 illustrates an embodiment that provides an adjustable four-portarray of a plurality of cold plasma ports in an annular orientation.

FIG. 3 illustrates an embodiment of a four-port, adjustable array (in aclosed position) of a plurality of cold plasma ports in an annularorientation.

FIG. 4 illustrates an embodiment where two cold plasma ports arepositioned to be diametrically opposed to one another, with convergenceof the resulting cold plasma jets occurring between the two cold plasmaports.

FIG. 5 illustrates a flowchart of a method for providing two or morecold plasma jets that converge at a treatment area, according to anembodiment of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

Cold temperature plasmas have attracted a great deal of enthusiasm andinterest by virtue of their provision of plasmas at relatively low gastemperatures. The provision of plasmas at such a temperature is ofinterest to a variety of applications, including wound healing,anti-bacterial processes, tumor treatments, anti-inflammatorytreatments, non-infective disorders that may be treatable with coldplasmas, and various other medical therapies and sterilization.

Conventional cold plasma treatments were focused on treatment areas atthe surface of the skin, as it was not previously known that coldplasmas could penetrate the surface of the skin. Consequently, nocontemplation was previously considered as to approaches by which coldplasma penetration for treatment purposes could be improved oroptimized. However, recent data that is described in U.S. patentapplication Ser. No. 14/026,679, entitled “Therapeutic Applications ofCold Plasma,” filed Sep. 13, 2013, indicate that subcutaneous treatmentprotocols are feasible with cold plasmas. In particular, paragraphs[0084]-[0089] of this referenced application provide data in support ofthe proposition that cold plasma penetrates beneath the skin so thatinternal tissue treatments are feasible.

Consideration of the penetration effects of cold plasma indicates thatthe penetration can be thought of as a cone of attenuation below theskin surface. The cold plasma intensity decreases due to the spreadingeffect associated with the conical penetration shape below the skinsurface. It is therefore desirable to be able to increase thepenetration and/or to increase the intensity at various depths below thesurface of the skin. By generating multiple “cones” of treatment in thetissues, with some degree of overlap, the desirable effects in deeptissues can be amplified. Therefore, increasing the intensity at varioustargeted depths below the skin surface, the volumetric problem ofcertain internal tissues disorders can be addressed.

Embodiments of the present disclosure include an annular device designedwith an array of two or more individual cold plasma (CP) jet portsoriented to converge about a patient's body segment (either at the skinsurface or below the skin surface) resulting in a plurality of treatmentangles (FIG. 1). The effective penetration of a typical cold plasma jetis generally on the order of <2 cm. By arranging a plurality of jetscircumferentially around the desired treatment zone, penetration todeeper tissues is possible and more complete. Embodiments of the coldplasma annular treatment device can be used to treat sub-integumentalinfections, such as abscess, bone, and joint infections, withoutsurgically opening the tissues overlying the deeper infection. Theability to treat deep infections of the soft and hard tissues of thebody without surgical intervention greatly reduces the risk of secondarycomplications (comorbidities), reduces pain, and decreases the cost oftreating these infections. Other beneficial applications of cold plasma,such as treating tumors or musculoskeletal disorders would also benefitfrom improved penetration.

The device, designed similarly to a modern magnetic resonance imaging(MRI) machine, allows the patient's injured or infected segment to beplaced inside of the machine, which is designed in an annular shape tosurround the affected area. FIG. 2 illustrates an adjustable symmetricalarray of cold plasma ports surround the segment to apply a treatment ofthe desired duration and intensity. The array could consist of anynumber of ports (FIG. 1, for example, illustrates 4 ports, but two ormore ports are contemplated to be within the scope of the presentdisclosure) to expand the degree of coverage of treatment through anoverlapping and/or converging plurality of plasma jets. The annulararray could be molded in unique sections, such as four sections (FIG. 2)and assembled after manufacture. The ports themselves can be designedand manufactured to each provide a cold plasma jet, using any approachknown to one skilled in the art. As an example (which is not intended tobe limiting), the cold plasma jet sources may be the multi-frequencyharmonic-rich cold plasma (MFHCP) devices described in U.S. ProvisionalPatent Application No. 60/913,369, U.S. Non-provisional application Ser.No. 12/038,159 (that has issued as U.S. Pat. No. 7,633,231) and thesubsequent continuation applications (collectively “the '369 applicationfamily”), which are incorporated herein by reference. Included in thedescription in U.S. Pat. No. 7,633,231 are devices that form cold plasmawithout the use of internal ground electrodes. Furthermore, the highvoltage RF power supply may be (but not limited to) that described inthe '369 patent family, or in U.S. patent application Ser. No.13/620,118, filed Sep. 14, 2012, which is also incorporated herein byreference. In both the cold plasma device and high voltage RF powersupply, the scope of this invention is not limited to these particularexamples, but covers all cold plasma devices and high voltage RF powersupplies.

On the cold plasma annular treatment device, the devices would beactivated remotely by a common trigger mechanism to generate plasma.This common trigger mechanism could be a physical flow control or acomputer console that triggers a plurality of valves and RF energy. Thedevices would be affixed to the annular array, as illustrated forexample in FIG. 1.

FIG. 1 illustrates an embodiment of the cold plasma annular treatmentdevice that includes a symmetrical array of a plurality of plasma ports.In this embodiment, four (4) ports 120 a, 120 b, 120 c, 120 d areillustrated, although two or more ports falls within the scope ofvarious embodiments of the present invention. Attached to each port is acold plasma generation unit 110 a, 110 b, 110 c, 110 d with the plasmaflow directed as shown to converge at an interior region. Each coldplasma generation unit 110 is connected by a high-voltage RF feed cable160 to one or more high voltage RF power supplies 150, and a gas supplyline 130 to a suitable supply of gas 140. The cold plasma annulartreatment structure can be modified to fit the appropriate sizepermitted by the each of the plasma ports, as well as the intendedtreatment area. A sliding/locking mechanism 170 is illustrated thatallows the cold plasma annular treatment structure to expand or contractas necessary to make the appropriate physical accommodation. The highvoltage RF power supplies can be similar to those described in the '369application family.

FIG. 2 illustrates an embodiment that provides an adjustable four-portarray of a plurality of cold plasma ports 220 in an annular orientation.Since the distance between the plasma outlet port and treatment targetare critical for effective treatment and tissue penetration, theinternal treatment area of the array can be adjusted to optimize thedistance between the plasma outlet ports and the target area (e.g., apatient's body segment) undergoing treatment. Sliding/locking mechanism170 may be in an open position 210, or in a closed position 230.Sliding/locking mechanism 170 makes use of an adjustment track 240. Thearray can be expanded or contracted as needed, and locked into place toensure consistent and optimized treatment distances. As can be readilysurmised by an examination of the Figures, the array can be adjusted inone direction, or in a second direction. The second direction can beorthogonal, or at another suitable angle, to the first direction. Suchadjustment directions are merely exemplary, and serve to illustrate theflexibility of adjustment envisaged for various embodiments within thescope of the present invention.

FIG. 3 illustrates an embodiment of a four-port, adjustable symmetricalarray (in a closed position using sliding/locking mechanism 310) of aplurality of cold plasma ports in an annular orientation. Although FIG.3 illustrates the possibility of four ports, only two ports 320 a, 320 bare occupied for this particular treatment regime. As expected, coldplasma 330 a, 330 b emanates and converges to a treatment area (notshown). In this embodiment, the two cold plasma sources are on the sameside of the treatment area.

In the context of this application, an annular cold plasma structureincludes the scenario where two cold plasma ports are aligneddiametrically opposed to one another, with a treatment area located inbetween the two cold plasma ports to receive cold plasma from those twocold plasma ports. FIG. 4 illustrates such an embodiment, with coldplasma devices 430 a, 430 b positioned to be diametrically opposed toone another. Each cold plasma device 430 receives a source of electricalenergy via high voltage RF feed line 420 and gas via gas feed line 410.Cold plasma 440 a, 440 b emanates from cold plasma devices 430 a, 430 bto reach treatment area (not shown) that is in between cold plasmadevices 430 a, 430 b.

FIG. 5 provides a flowchart of a method for providing two or more coldplasma jets that converge at a treatment area, according to anembodiment of the present disclosure.

The process begins at step 510. In step 510, electrical energy isreceived at two or more cold plasma devices, wherein the cold plasmadevices are located on an annular structure.

In step 520, gas is received at the two or more cold plasma devices.

In step 530, cold plasma is output from the two or more cold plasmadevices so as to converge at a treatment area.

At step 540, method 500 ends.

Although the above description has used the '369 application family asthe baseline cold plasma device, the scope of the present invention isnot limited to the '369 application family baseline. The '369application family baseline is merely exemplary and not limiting, andtherefore embodiments of the present invention include the deployment ofthe above annular features to cold plasma generation devices in general,irrespective of their means of generation.

As noted above, the four-port configuration is exemplary, and not alimiting of various embodiments of the present invention. Other numbersof ports fall within the scope of various embodiments of the presentinvention. Further, although a symmetric configuration is describedabove, non-symmetric or asymmetric configurations of ports can also beused to provide a particular treatment protocol, and suchnon-symmetric/asymmetric configurations also fall within the scope ofvarious embodiments of the present invention.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections, is intended to be used to interpretthe claims. The Summary and Abstract sections may set forth one or morebut not all exemplary embodiments of the present invention ascontemplated by the inventor(s), and thus, are not intended to limit thepresent invention and the appended claims in any way.

The present invention has been described above with the aid offunctional building blocks illustrating the implementation of specifiedfunctions and relationships thereof. The boundaries of these functionalbuilding blocks have been arbitrarily defined herein for the convenienceof the description. Alternate boundaries can be defined so long as thespecified functions and relationships thereof are appropriatelyperformed.

The foregoing description of the specific embodiments will so fullyreveal the general nature of the invention that others can, by applyingknowledge within the skill of the art, readily modify and/or adapt forvarious applications such specific embodiments, without undueexperimentation, without departing from the general concept of thepresent invention. Therefore, such adaptations and modifications areintended to be within the meaning and range of equivalents of thedisclosed embodiments, based on the teaching and guidance presentedherein. It is to be understood that the phraseology or terminologyherein is for the purpose of description and not of limitation, suchthat the terminology or phraseology of the present specification is tobe interpreted by the skilled artisan in light of the teachings andguidance.

The breadth and scope of the present invention should not be limited byany of the above-described exemplary embodiments, but should be definedonly in accordance with the following claims and their equivalents.

What is claimed is:
 1. An apparatus comprising: an annular structurehaving two or more cold plasma devices positioned to provide convergingcold plasma jets that converge at a treatment area, wherein at least oneof the two or more cold plasma devices is coupled to one or moreharmonic high voltage RF power supplies.
 2. The apparatus of claim 1,wherein the two or more cold plasma devices are positioned in acircumferential orientation.
 3. The apparatus of claim 1, furtherconfigured to include a plurality of port locations, wherein the two ormore cold plasma devices occupy a subset of the plurality of portlocations.
 4. The apparatus of claim 1, wherein the annular structure isadjustable, the annular structure being further configured to belockable to ensure a predetermined alignment of the two or more coldplasma devices.
 5. The apparatus of claim 1, wherein the two or morecold plasma devices are configured to generate two or more cold plasmajets that are diametrically opposed to one another, the treatment areabeing located between the two or more cold plasma devices.
 6. Theapparatus of claim 1, wherein the two or more cold plasma devices arecoupled to a common triggering mechanism to simultaneously activate thetwo or more cold plasma devices.
 7. The apparatus of claim 1, whereinfunctionality settings of the two or more cold plasma devices areindependently configurable to provide a desired treatment regime at thetreatment area.
 8. The apparatus of claim 7, wherein the functionalitysettings of the two or more cold plasma devices include computercontrol.
 9. The apparatus of claim 1, wherein at least one of the two ormore cold plasma devices is a multi-frequency harmonic-rich cold plasmadevice.
 10. The apparatus of claim 1, wherein at least one of the two ormore cold plasma devices is free of internal ground electrodes.
 11. Amethod comprising: receiving, from one or more high voltage RF powersupplies, electrical energy at two or more cold plasma devices, whereinthe two or more cold plasma devices are located on an annular structure;receiving, from a gas source, gas at the two or more cold plasmadevices; and outputting cold plasma from the two or more cold plasmadevices to converge at a treatment area.
 12. The method of claim 11,wherein the two or more cold plasma devices are located in acircumferential orientation.
 13. The method of claim 11, wherein theannular structure includes a plurality of port locations, and whereinthe two or more cold plasma devices occupy a subset of the plurality ofport locations.
 14. The method of claim 11, wherein the annularstructure is adjustable, the method further including: locking theadjustable annular structure to ensure a predetermined alignment of thetwo or more cold plasma devices.
 15. The method of claim 11, whereinoutputting cold plasma from the two or more cold plasma devices includesoutputting cold plasma in jets that are diametrically opposed to oneanother, the treatment area being located between the two or more coldplasma devices.
 16. The method of claim 11, wherein the two or more coldplasma devices are coupled to a common triggering mechanism tosimultaneously activate the two or more cold plasma devices.
 17. Themethod of claim 11, wherein functionality settings of the two or morecold plasma devices are independently configurable to provide a desiredtreatment regime.
 18. The method of claim 17, further including:computing controlling the functionality settings of the two or more coldplasma devices.
 19. The method of claim 11, wherein at least one of thetwo or more cold plasma devices is a multi-frequency harmonic-rich coldplasma device, and outputting cold plasma includes outputtingmulti-frequency harmonic-rich cold plasma.
 20. The method of claim 11,wherein receiving electrical energy at two or more cold plasma devicesincludes receiving electrical energy at at least one of the two or morecold plasma devices, wherein the at least one of the two or more coldplasma devices is free of internal ground electrodes.